BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 3140150 · Received May 29, 2013

    Report

    Report Number
    1052693-2013-00084
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 29, 2013
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NOT YET RETURNED FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF LOW BLOOD GLUCOSE RESULTS. PER THE CALLER, RESULTS IN MEMORY FROM THIS AFTERNOON WERE 67MG/DL, 67MG/DL AND 49MG/DL ABOUT 3 HOURS AFTER BREAKFAST. CALLER STATES HIS GLUCOSE IS NORMALLY 100MG/DL - 110MG/DL 2 HOURS AFTER A MEAL. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235782 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PP1176

    Patients

    Seq Age Sex Outcome Treatment
    1